Efficacy and Safety Evaluation of Fecal Microbiota Transplantation in Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Response rate at 9 weeks
研究概览
简要总结
Participants will be given FMT through oral capsules or nasojejunal tube once a month. After three-time treatment, participants were followed up for three months. Participants complete specific scales to assess improvement in symptoms, emotion and quality of life. Besides, they report adverse effects and collect fecal samples at each visit.
详细描述
This prospective, single-arm interventional study aims to evaluate efficacy and safety of fecal microbiota transplantation in refractory IBS patients. Patients meeting the inclusion and exclusion criteria will provide written informed consent and receive FMT from healthy donors for three times. The administration methods include taking oral capsule or delivering microbiota suspension into the duodenum via nasojejunal tube. The patients receive treatment once a month and will be followed up for 3 months. Improvement in IBS symptoms, emotion and quality of life were assessed through IBS symptom severity scale (IBS-SSS), Gastrointestinal symptom rating scale (GSRS), IBS-Global Assessment of Improvement (IBS-GAI), Self-rating Anxiety Scale (SAS), Self-rating Depression Scale (SDS) and IBS-Quality of Life (IBS-QoL) respectively. Patients were asked to complete these scales and collect fecal samples at baseline, post-FMT and at 1, 2, 3 and 4 months after FMT. Primary endpoints were improvement in IBS-SSS score and global symptoms after three-time FMT. Secondary endpoints include Change in GSRS score, improvement in emotion and quality of life at post-FMT, 1 and 6 months, as well as change in fecal microbiota composition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who fulfilled the Rome IV criteria for the diagnosis of IBS, aged 18-70 years;
- •Patients who have experienced failure of at least 3 conventional therapies for IBS;
- •Absence of red flags such as weight loss, hematochezia;
排除标准
- •Pregnant, planning pregnancy or lactating;
- •Psychiatric disorder or unable to cooperate with treatment and follow-up visit;
- •Immunodeficiency or treatment with immune-modulating medication;
- •Use of probiotics within the previous 3 months or treatment with antibiotics within 1 month prior to study entry;
- •Having undergone any abdominal surgery, with the exception of appendectomy, cholecystectomy, caesarean section and hysterectomy;
- •Presence of uncontrolled diabetes, hypertension, thyroid disease or other systemic disease;
- •Presence of severe diseases related to heart, brain, kidney and lung or concomitant malignancies;
研究组 & 干预措施
FMT
Participants will be given FMT through oral capsules or nasojejunal tube once a month for three months.
干预措施: FMT (Other)
结局指标
主要结局
Response rate at 9 weeks
时间窗: at 9 weeks
Investigator ask participants a single question, "Compared to the way you felt before you entered the study, have you IBS symptoms over the past 7 days been: 1)"Substantially Worse"; 2)"Moderately Worse"; 3) Slightly Worse; 4)"No Change"; 5) Slightly Improved"; 6) Moderately Improved"; 7) Substantially Improved". Responder is defined as participants who report "moderately improved" or "substantially improved".
Change from baseline IBS symptom severity scale (IBS-SSS) score at 9 weeks
时间窗: at baseline and 9 weeks
IBS symptom severity scale (IBS-SSS) is used to evaluate change in IBS symptoms, with a score ranging from 0 to 500. Higher score means severer IBS symptom. Change in IBS-SSS score is obtained by evaluating the scale at baseline and 9 weeks (after three-time FMT).
次要结局
- Change from baseline IBS symptom severity scale (IBS-SSS) score at 1 week, 1 month and 6 months(at baseline, 1 week, 1 month and 6 months)
- Change from baseline fecal metabolites at 1 week, 1 month and 6 months(at baseline, 1 week, 1 month and 6 months)
- Change from baseline Self-rating Anxiety Scale (SAS) score at 1 month, 3 months and 6 months(at baseline, 1 month, 3months and 6 months)
- Change from baseline Self-rating Depression Scale (SDS) score at 1 month, 3 months and 6 months(at baseline, 1 month, 3months and 6 months)
- Change from baseline IBS-Quality of Life (IBS-QoL) score at 1 month, 3 months and 6 months(at baseline, 1 month, 3months and 6 months)
- Response rate at 1 week, 1month, 3 months and 6 months(at 1 week, 1month, 3 months and 6 months)
- Change from baseline fecal microbiota composition at 1 week, 1 month and 6 months(at baseline, 1 week, 1 month and 6 months)
- Change from baseline Gastrointestinal Symptom Rating Scale (GSRS) score at 1 week, 1 month, 9 weeks and 6 months(at baseline, 1 week, 1 month, 9 weeks and 6 months)